Completed

NCT Number: NCT00014742

Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease

OBJECTIVES: I. Compare the safety and efficacy of clostridial collagenase vs placebo in terms of improving the degree of flexion deformity, range of finger motion, and grip strength in patients with residual stage Dupuytren's disease.

II. Compare the overall clinical success rate, time to return to normal finger contracture to within 0-5 degrees of normal (zero degrees), and frequency of cord rupture in the joint of patients treated with these regimens.

III. Compare the baseline change in degree of finger flexion deformity, range of motion of the treated finger, and strength of hand grip (in pounds) in patients treated with these regimens.

IV. Compare the frequency distribution of the number of patients with reduction in finger contracture to within 0-5 degrees of normal (zero degrees) and the number who require re-treatment with open-label collagenase after treatment with these regimens.

Completed

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Key information

Conditions

Dupuytren's Contracture Arthritis Connective Tissue Diseases Contracture Disease Attributes Dupuytren Contracture Fibroma Joint Diseases Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

PROTOCOL OUTLINE: This is a randomized, investigator-blinded, placebo-controlled, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive a single collagenase injection into the target finger cord on day 0.

Arm II: Patients receive a single placebo injection as in arm I.

Both arms: After the 1 month evaluation, patients who are unresponsive to treatment may receive monthly injections of collagenase for a maximum of 5 injections.

Beginning at 1 day after completion of treatment, patients use a joint nighttime extension splint for 4 months and perform finger flexion/extension exercises.

Patients are followed at 1, 7, and 14 days, monthly for 3 months, every 3 months for 9 months, and then annually for 4 years.

Completion date provided represents the completion date of the grant per OOPD records

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of residual stage Dupuytren's disease with fixed flexion deformity of the finger(s) of at least 20-30 degrees caused by a palpable cord

Positive table-top test (inability to simultaneously place affected finger and palm flat against a table top)

--Prior/Concurrent Therapy--

At least 30 days since prior surgery for Dupuytren's disease At least 30 days since prior participation in a trial with an investigational drug

--Patient Characteristics--

Hematopoietic: No history of hematologic disease

Hepatic: No history of hepatic disease

Renal: No history of renal disease

Cardiovascular: No congestive heart failure, angina, or myocardial infarction within the past 6 months

Pulmonary: No history of respiratory disease

Other:

Not immunocompromised
HIV negative
No history of significant illness (e.g., endocrine or neurologic disease)
No psychosis
No history of illicit drug abuse or alcoholism within the past year
No infectious illness within the past 2 weeks
No chronic or debilitating disease
No IgE antibodies to collagenase exceeding 15 ng/mL
No known allergy to collagenase or any of the inactive ingredients in the drug
No other condition or circumstance that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

Treatment and study plan

Collagenase

Drug

Sponsors and collaborators

Lead sponsor

State University of New York

Other

Registry information

Important dates

Study completion: 2004
First posted: Apr 11, 2001
Registry last updated: Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed